Idiopathic pulmonary fibrosis Respiratory Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
Healthcare professionals, family caregivers and adults living with IPF will be recruited by the Metro Centre for Respiratory Diseases (MCRD). Due to the nature of this trial, the precise details and c
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. People eligible for inclusion in the home-based PR trial will be: 1.1. Aged =18 years 1.2. Confirmed diagnosis of IPF according to European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines 1.3. Willing to provide informed consent 2. Healthcare professionals who have at least 1 year of experience and work directly with IPF patients, including specialists, nurses and physiotherapists 3. Family caregivers who have and/or care for a family member diagnosed with IPF
Exclusion criteria
Exclusion criteria: Adults with comorbidities such as severe or unstable cardiovascular disease, other internal diseases and locomotor difficulties that preclude the exercise or malignant disease or other serious illness which will interfere with participation in the study, will be excluded. Individuals not eligible for the study will be recorded on a study screening log.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measures to assess feasibility are provided below and include the comprehensive assessment of the feasibility of patient recruitment and the intervention delivery: 1. Feasibility of screening and recruiting participants, suitability of the inclusion criteria assessed through screening of patients records and data sources (week 0) 2. Number of eligible patients, number of patients screened, number of patients invited to take part, and the actual number of participants who consent to take part, assessed using study notes and screening log (week 0) 3. Number of patients who refuse, drop out and the reasons for refusing and dropping out, assessed using drop-out interview and information provided freely by the participants collected as field notes (week 6) 4. Operational experience of intervention delivery assessed using semi-structured in-depth interviews at week 0 and week 6 5. Service provider and multi-disciplinary teams’ willingness and ability to deliver the intervention, assessed using semi-structured in-depth interviews at baseline with healthcare professionals (week 0 and week 6) 6. The practicality of delivering the intervention in the proposed setting, assessed using semi-structured in-depth interviews (week 0 and week 6) 7. The time needed to collect the data at both baseline and follow-up visit through the recording of the time from rehabilitation records needed for each measure (week 0 and week 6) 8. Data completeness and accuracy assessed with healthcare professional interviews rehabilitation records from the research team (week 6) 9. Adherence to home exercise assessed using interviews with patients and a self-report exercise diary (week 6) 10. The training and resources needed to deliver the intervention (ensuring readiness for a future much larger multi-center trial) assessed using semi-structured in-depth interviews and rehabilitation records (week 0 and week 6) 11. Description of unintended events using a data collection form with an adverse events lo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Socio-demographics assessed using questionnaires at baseline (Week 0) 2. Lung health assessed using spirometry data records, lung transfer factor, and smoking status questions at baseline (week 0) 3. Comorbidities assessed using questionnaires at baseline (week 0) 4. Treatments assessed using questionnaires at baseline (week 0) 5. Physical measurements such as blood pressure and temperature, assessed using appropriate equipment such as cuff, automated blood pressure monitor and thermometer at baseline (week 0) Measured at baseline (at week 0) and the end of the trial (at week 6): 1. Perceived respiratory disability due to dyspnea assessed using the Medical Research Council (MRC) dyspnea scale 2. Health-related quality of life assessed using the chronic obstructive pulmonary disease assessment test (CAT) 3. Economic impact assessed using the Work Productivity and Activity Impairment (WPAI) questionnaire 4. Quality of life assessed using King's Brief Interstitial Lung Disease (KBILD) and EuroQol Five Dimension Five Levels (EQ-5D-5L) 5. Psychological well being assessed using the Hospital Anxiety and Depression scale 6. Physical fitness variables such as: 6.1. Exercise capacity measured using the incremental shuttle walk test (ISWT) and the endurance shuttle walking test (ESWT) 6.2. Lower extremity muscular strength measured using a five-repetition sit-to-stand test (5XSST) | — |
Countries
India
Contacts
Public ContactMark Orme
Outcome results
None listed